Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Cardiopulmonary exercise testing before and after blood transfusion: a prospective clinical study

Acronym

Study hypothesis

That a blood transfusion has no effect on a patient's ability to exercise as judged by Cardio-Pulmonary Exercise Testing (CPX) testing.

Ethics approval

Not provided at time of registration

Study design

Single-centre prospective clinical study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anaemia

Intervention

Blood transfusion: 1. We are investigating anaemic haematology patients and determining their exercise capacity before and after transfusion by means of cardio-pulmonary exercise testing2. Each patient will undergo exercise testing twice before transfusion (1-3 days before and on the day of transfusion) and once afterwards (3-5 days after)3. A blood sample to check Hb concentration will be undertaken at the time of each test 4. Comparing the results of tests one and two will allow us to determine the intra-patient variability of the test in this population, while comparing tests two and three will allow us determine the physiological effects of transfusion

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The change in anaerobic threshold following blood transfusion

Secondary outcome measures

1. The change in AT per unit (g/dL) change in Hb concentration will be determined to correct for the variable change in Hb seen with blood transfusion2. Changes in other CPX variables following transfusion, including peak VO2, OEUS (Oxygen Efficiency Utilisation Slope), Ve/VCO2 ratio, VO2/HR ratio and Respiratory Exchange Ratio (RER)3. Intra-patient variability in the AT measured by CPX testing will be expressed as the coefficient of variation

Overall trial start date

01/02/2011

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients requiring blood transfusion under the care of the haematology team2. Patients over the age of 18 years 3. Capacity to give informed consent4. Comprehension of English5. Ability to undertake CPX testing using a cycle ergometer

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

28

Participant exclusion criteria

1. A requirement to have an urgent blood transfusion as judged by the haematologist caring for the patient. (This would not allow sufficient time to undertake proper consent and perform CPX tests one and two).2. Ongoing active bleeding3. Those who get angina or intermittent claudication on moderate exercise or who have shortness of breath at rest4. Patients who have a significant acute medical illness5. Those with other contraindications to exercise testing according to the ACC/AHA Exercise Testing Guidelines or our own local guidelines